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Mesothelioma Clinical Trial Review – UCLA Jonsson Comprehensive Cancer Center

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c-trialsWe encourage participation in clinical trials for research leading to a cure for mesothelioma. It is known that nationally the statistics for participation in adult clinical cancer trials is between 3-5% of adults who have a cancer diagnosis.

For mesothelioma patients and families who are interested in clinical trials, researching clinical trials and eligibility can be a time consuming barrier to participation. The information about clinical trials is available on www.clinicaltrials.gov. You can also send for our user-friendly Mesothelioma Clinical Trial Digest.

Our goal is to feature one mesothelioma clinical trial monthly and break it down to understandable terms, to decipher the eligibility requirements, and to possibly encourage participation in these trials.

CLINICAL TRIAL- NCT02672033

Accelerated Hypofractionated Radiation Therapy Immediately Before Surgery in Treating Patients with Malignant Pleural Mesothelioma

Official Title- Neoadjuvant Accelerated Hypofractionated Radiation Therapy Immediately Prior to Radical Pleurectomy/Decortication for Malignant Pleural Mesothelioma- A Pilot Study

Listing on www.clinicaltrials.gov

Sponsor- Jonsson Comprehensive Cancer Center

National Cancer Institute (NCI)

Location- UCLA Jonsson Comprehensive Cancer Center, Los Angeles California

Principal Investigator- Percy Lee M.D.

Contact-Percy Lee, M.D. 310 825 9775   PercyLee@mednet.ucka.edu

Number of Participants- 10

Purpose- “This pilot phase 0 trial studies accelerated hypofractionated radiation therapy immediately before surgery in treating patients with malignant pleural mesothelioma (cancer in the thin layer of tissue that covers the lungs and lines the interior lining of the chest cavity). Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Hypofractionated radiation therapy is a type of radiation therapy in which the total prescribed dose of radiation is divided into fewer but larger doses as compared to conventional radiation therapy. Giving accelerated hypofractionated radiation therapy immediately before surgery may improve survival, and may also reduce side effects experienced by patients with pleural mesothelioma.”

Screening- Must be eligible for surgery- all lab tests and scans pre-op- which include- blood tests, X-rays, scans, EKG.

Eligibility Criteria- Histologically confirmed epithelioid predominantly (>70%) subtype malignant pleural mesothelioma

Patients must have been evaluated at the University of California Los Angeles (UCLA) thoracic surgeon, and deemed medically and technically suitable for a pleurectomy/decortication procedure.

Karnofsky performance status (KPS) >=70 or Eastern Cooperative Oncology Group (ECOG) 0-2

If a women of child bearing potential, a negative urine or a serum pregnancy test must be documented, women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control, or abstinence) for duration of study participation and for up to 4 weeks after the study.

Exclusions- Patients who have previously received therapeutic radiation therapy to the chest

Active systemic, pulmonary, or pericardial infection

Use of chemotherapy within 4 weeks of the planned start of radiation therapy.

Pregnant women, or women of child bearing potential who are sexually active and not willing/able to use medically acceptable forms of contraception for the entire study period and for up to 4 weeks after the study

Refusal to sign the informed consent

Patients who are participating in a concurrent treatment protocol

How the research study is designed to work-“Patients undergo 5 sessions of accelerated hypofractionated intensity- modulated radiation therapy (IMRT) over 1 week with simultaneous integrated boost to gross disease. Patients then undergo pleurectomy/decortication within 14 days after completion of IMRT. After completion of study treatments, patients are followed up to 6 weeks, and then every 3months for 5 years.”

With any clinical trial, all participation is voluntary. Before enrollment a detailed consent form will be reviewed with the participant and signed. The participant can withdraw from a clinical trial at any point in time. Think about participating if able, the only way progress to a cure for mesothelioma can be made is through clinical trials.

If you have any questions, let us know.

Mesothelioma Clinical Trial Review – MEDI 4736

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c-trialsWe encourage participation in clinical trials for research leading to a cure for mesothelioma. It is known that nationally the statistics for participation in adult cancer trials is between 3-5% of adults who have a cancer diagnosis.

For mesothelioma patients and families that are interested in clinical trials, researching clinical trials and eligibility can be a time consuming barrier to participation. The information about clinical trials is available on www.clinicaltrials.gov.

Our goal is to feature one mesothelioma clinical trial monthly and break it down to understandable terms, to decipher the eligibility requirements, and to possibly encourage participation in these trials.

CLINICAL TRIAL- NCT02592551

Med14736 or Med14736 + Tremelimumab in Surgically Resectable Malignant Pleural Mesothelioma

Official Title- Window of Opportunity Phase 11 Study of MED14736 or MED14736 + Tremelimumab in Surgically Resectable Malignant Pleural Mesothelioma

Listing on www.clinicaltrials.gov

Sponsor:   Baylor College of Medicine

Location:   Baylor St. Lukes Houston Texas

Principal Investigator:   Bryan Burt MD. Baylor College of Medicine

Contact:     Michelle G Almarez BBA 713 798 3680 Michelle.Almarez@bcm.edu

Or:             Bryan Burt MD 713 798 8266   Bryan.Burt@bcm.edu

Purpose: The objective of this study is to determine whether MEDl4736 or combination therapy with MEDl4736 + tremelimumab are associated with favorable alterations of the intratumoral immunologic environment in subjects undergoing surgery for Malignant Pleural Mesothelioma.

Screening:

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Adequate normal organ and marrow function as defined below: Hemoglobin > 9.0 absolute neutrophil count (ANC) greater than 1.5 x109/lL, platelet count greater than 100,000, serum bilirubin less than 1.5x institutional limits, creatinine clearance less than 2.0 or calculated creatinine clearance greater than 50 ml/min as determined by the Cockcroft-Gault equation.

Any malignant pleural mesothelioma epithelial, mixed or sarcamatoid

N2 Nodal disease if no progression after 2 cycles of chemotherapy

NO or N1 nodal disease as present on perioperative chest ct or pet ct

Eligibility Criteria:

  • Patients must be 18 years of age
  • Eastern Cooperative performance status of 0 or 1 Females must be non-reproductive potential (post-menopausal, hysterectomy, bilateral tubular ligation, oophorectomy or have negative serum pregnancy test.
  • Patient is willing to adhere to protocol
  • Have pleural mesothelioma constricted to one lung. Patient is staged at NO or N1 determined by chest ct or pet ct
  • Have N2 disease no progression after 2 cycles of chemotherapy. Patient will be considered if N1 or N2 develops during chemotherapy.

Exclusion Criteria:

  • Patient involved in another clinical trial within 3 months
  • Any treatment with PD1 or PDL-1 inhibitor including MEDI4736
  • N3 nodal disease
  • Uncontrolled seizures
  • Previous diagnosis of tuberculosis
  • History of transplant
  • Pregnant or breastfeeding
  • Uncontrolled brain metastasis requiring treatment
  • Known history of immunodeficiency
  • Hypersensitivity to MEDI4736 or tremelimumab
  • Uncontrolled illness including heart failure, angina, peptic ulcer disease, gastritis, active bleeding, chronic hepatitis b or c, HIV, psychiatric illness
  • History of leptomenigeal carcinomatosis
  • Had drugs with laxative properties and herbal or natural remedies for constipation within 90 days of receiving MEDI 4736 or MEDI and tremelimumab
  • Had vaccine within 30 days of receiving tremelimumab or within 6 months of receiving MEDI4736 or MEDI and Trememlimumab
  • Had sunitinib within 3 months of receiving tremelimumab
  • If you have had active or prior documented bowel disease
  • Active or prior documented autoimmune disease within the last 2 years
  • Any adverse event while receiving immunotherapy
  • Any toxicity while receiving cancer treatment
  • Any immunosuppressive drugs 28 days prior to to the clinical trial drugs and 90 days’ post infusion of treatment drug
  • Mean QT interval corrected for heart rate (QTc) > 470 ms calculated from 3 electrocardiograms (ECG’s) using Bazett’s Correction
  • Had any chemotherapy ,immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization ,monoclonal antibodies, other investigational drugs 30 days prior to first dose of study drug

How the Research Study is designed to work

Patients who have malignant pleural mesothelioma undergo a cervical mediastinal lymph node biopsy and also simultaneously undergo a biopsy of the pleura by thorcoscopy. The biopsy tissue must be 2 grams. In addition to these biopsies patient will also have blood drawn for this study. Approximately 1-2 weeks’ patients will be given MEDI-4736(15mg/kg once intravenously) or MEDI-4736(1500 mg once intravenous) also will receive tremelimumab (75 mg once intravenously) or a control group. There will be 2 treated arms and one controlled arm (untreated). Approximately two or three weeks’ patient will undergo surgical resection surgery either extra pleural pneumonectomy, or pleurectomy, and decortication. During this surgery the tumor will be removed and studied. At the initiation of surgery blood will be taken. Also the sixth rib will be removed at time of surgery. The surgery will include the standard treatment which includes intraoperative chemotherapy .

Sources:

www.ClinicalTrials.gov

With any clinical trial all participation is voluntary. Before enrollment a detailed consent form will be reviewed with the participant and signed. The participant can withdraw from a clinical trial at any point in time. Think about participating if able, the only way to progress to a cure for mesothelioma is through clinical trials.

Please do not hesitate to contact us with any questions.

Some of the terms used in the description of clinical trials can be confusing. For this clinical trial a definition of some of the terms are below.

Durvalumab- code name MEDI4736 or MEDI-4736- is a Fc optimized monoclonal antibody directed against cell death-1 ligand, with potential immune checkpoint inhibitory and anti-neoplastic activity. When given intravenously it binds to PD-L1- it then will reverse T-cell inactivation and activate the immune system to exert a cytotoxic T lymphocyte (CTL) response against PD-L1 expressing tumor cells.

Tremelimumab- code name CP-675 CP-675,206 – A human immunoglobulin (Ig) G2 monoclonal antibody directed against the human T-cell receptor protein cytotoxic T-lymphocyte associated protein 4 (CTLA4), with potential immune check point inhibitory and antineoplastic activities.

Source: National Cancer Institute Drug Dictionary

 

Mesothelioma Clinical Trial Review (Transarterial Chemoperfusion)

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We encourage participation in clinical trials for research leading to a cure for mesothelioma. It is known that nationally the statistics for participation in adult cancer trials is between 3-5% of adults who have a cancer diagnosis.

For mesothelioma patients and families who are interested in clinical trials, researching clinical trials and eligibility can be a time consuming barrier to participation. The information about clinical trials is available on www.clinicaltrials.gov.

Our goal is to feature one mesothelioma clinical trial monthly and break it down to understandable terms, to decipher the eligibility requirements, and to possibly encourage participation in these trials.

CLINICAL TRIAL- NCT02611037

Transarterial Chemoperfusion: Cisplatin, Methotrexate, Gemcitabine for Unresectable Pleural Mesothelioma

Official Title- A Phase 2 Study of Transarterial Chemoperfusion Treatment with Cisplatin, Methotrexate and Gemcitabine in Patients with Unresectable Pleural Mesothelioma

Listing on www.clinicaltrials.gov

Sponsor: H. Lee Moffitt Cancer Study and Research Institute

Location: H Lee Moffitt Cancer Center and Research Institute Tampa, Florida

Principal Investigator: Bela Kis, M.D., Ph.D., H. Lee Moffitt Cancer Center and Research Institute

Contact: Malesa Pereira 1-888-663-3488 www.FloridaChestSurgery.com

Number of Participants: Expected to be about 36

Purpose:
This clinical trial is for patients who are not candidates for surgery, have disease progression, and pain. This is a palliative therapy to improve the quality of life of pleural mesothelioma patients who have unresectable recurrent pleural mesothelioma. The study is to determine whether transarterial chemoperfusion treatment with Cisplatin, Methotrexate and Gemcitabine in adult patients with malignant pleural mesothelioma is safe and at what dose.

Screening:
All baseline laboratory requirements will be assessed and should be obtained within 14 days of first treatment. Screening laboratory values must be met.

Must have histologically or cytological confirmed malignant pleural mesothelioma.

Have measurable disease, by a CT. scan or MRI. Radiological tumor assessment must be performed within 28 days prior to the first treatment.

Women must have a negative serum or urine pregnancy test within 24 hours prior to the start of transarterial chemo perfusion treatment.

Men must be surgically sterile or must agree to use adequate contraception prior to the study entry and for the duration of study participation and after for a certain amount of time (up to 14 weeks) after the last treatment

Eligibility Criteria:
• Must have histologically or cytologically confirmed malignant pleural mesothelioma (MPM)
• Have unresectable MPM or the patient refuses surgery for resectable MPM
• Have failed to respond first line standard of care chemotherapy or chemotherapy suspended due to toxicity or other reasons.
• The predominant burden of disease lies in the arterial distribution which is accessible for transarterial chemo perfusion treatment.
• Men and Women greater than 18 years of age
• Eastern Cooperative Oncology Group performance status 60%
• Ability to understand and the willingness to sign a written informed consent document
• Participants must have signed and dated an Institutional Review Board (IRB) approved written informed consent form in accordance with regulatory and institutional guidelines.
• Must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests, imaging studies, and other requirements of the study.

The study permits the re-enrollment of a participant who has discontinued the study for a reason other than treatment failure or adverse event of the study treatment.

Patients with the 3 types of mesothelioma (epithelial, sarcomatoid and biphasic) are all eligible

Exclusion Criteria:
• Patients who have had chemotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
• May not be receiving any other investigational agents
• Known brain metastases or leptomeningeal metastases. Patients with other extra pleural metastases are included in this study.
• History of allergic reactions to compounds similar to Cisplatin, Methotrexate, Gemcitabine
• Uncontrolled illness including other malignancy, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• Women who are pregnant or breast feeding
• Potential participants who are compulsorily detained for treatment of either a psychiatric or physical (e.g. infectious disease) illness.

How the Research Study Is Designed to Work:
Patients are given chemotherapy directly to the blood vessels feeding the tumor via a small catheter into the arteries feeding the tumor. The small catheter is placed temporarily into the femoral artery usually the groin of the patient, the catheter is fed up to the area of the tumor and then the chemotherapy is infused locally. By targeting the vessels feeding the tumor with chemotherapy agents it is hoped that the side-effects of the chemotherapy on the rest of the body are less. The process is repeated once a month.

Sources:
www.FloridaChestSurgery.com
www.ClinicalTrials.gov

With any clinical trial, all participation is voluntary. Before enrollment a detailed consent form will be reviewed with the participant and signed. The participant can withdraw from a clinical trial at any point in time. Think about participating if able, the only way to progress to a cure for mesothelioma is through clinical trials.
Please do not hesitate to contact us with any questions.

Mesothelioma Clinical Trial Review- Methoxyamine, Cisplatin And Pemetrexed

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c-trialsWe encourage participation in clinical trials for research leading to a cure for mesothelioma. It is known that nationally the statistics for participation in adult cancer trials is between 3-5% of adults who have a cancer diagnosis.

For mesothelioma patients and families who are interested in clinical trials, researching clinical trials and eligibility can be a time consuming barrier to participation. The information about clinical trials is available on www.clinicaltrials.gov.

Our goal is to feature one mesothelioma clinical trial monthly and break it down to understandable terms, to decipher the eligibility requirements, and to possibly encourage participations in these trials.

CLINICAL TRIAL- NCT02535312

Methoxyamine (TRC102), Cisplatin, and Pemetrexed Disodium in Treating Patients with Advanced Solid Tumors or Mesothelioma That Cannot Be Removed by Surgery or Mesothelioma That is Refractory to Cisplatin and Pemetrexed

Official Title- Phase I Study of TRC102 in Combination with Cisplatin and Pemextred in Patients with Advanced Solid Tumors, With Expansion Cohort in Mesothelioma/ Phase II Study of TRC102 with Pemetrexed in Patients Refractory to Cisplatin and Pemetrexed

Listing on www.clinicaltrials.gov

Sponsor- National Cancer Institute

Location- University of Maryland/ Greenebaum Cancer Center Baltimore Maryland- Contact Martin J. Edelman 800-888-8823

City of Hope Comprehensive Cancer Center Duarte, California, Contact Marianna Koczywas 800-826-4673

University of California Davis Comprehensive Cancer Center Sacramento, California, Contact Karen L. Kelly 916-734-7946

University of Colorado Cancer Center- Anschutz Cancer Pavilion Aurora, Colorado, Contact Stephen Leong 720- 848-0650

University of Michigan Comprehensive Cancer Center Ann Arbor Michigan, Contact Bryan J. Schneider

Mayo Clinic Rochester, Minnesota, United States Contact: Aoron S. Mansfield 507-538-7623

Number of Participants-58

Purpose- Clinical Trial TRC 102 in combination with 2 chemotherapy agents Cisplatin and Pemetrexed. This trial is for advanced tumors with expansion to mesothelioma/ Phase II is TRC102 and Pemetrexed in patients with refractory to cisplatin and Pemetrexed. NCI 9837

Group 1 is for previously treated cancers. Different doses of the study drug will be distributed in conjunction with Pemetexed and Cisplatin in patients who have been previously treated. The first group will receive the lowest dose of TRc102. If this does not cause serious side effects the dose will be increased for the next group of patients. The dose will be increased for each group until the side effects require the dose to be lowered.

Group 2 is for newly diagnosed patients with mesothelioma or solid tumors. The study drug TRC102 will be given in addition to Pemetrexed and Cisplatin. This group will be patients who would have been prescribed Pemetrexed and Cisplatin for regular treatment. The solid cancers include malignant mesothelioma, non small cell lung cancer, ovarian and thymome. The dose of group one will be based on the study of group 1.

Group 3 is for newly diagnosed malignant mesothelioma. All study participants will get the same drug (TRC102) with Pemetrexed and Cisplatin. This is for 14 study participants with previously untreated advanced, inoperable malignant mesothelioma for which Pemetrexed and Cisplatin is the regular treatment. The dose of TRC102 will be based on group 1.

Pemextred and Cisplatin will be given in conjunction with TRC102 on the first day of each cycle for 6 cycles. A treatment cycle is 3 weeks.

Eligibility Criteria

1 Patients with advance tumors in which standard treatments are not available. (Arm A)

2.Patients who have advanced unresectable solid tumors that are chemotherapy naïve for which Pemextred and Cisplatin is an indicated regime. (Arm A)

3.Group 3 patients with chemotherapy naïve and unrespectable malignant mesothelioma. ( Arm A)

4.Patients who have been treated but disease has progressed within 3 months of being treated with Cisplatin and Pemetrexed as a frontline appointment. (pleural or peritoneal mesothelioma) (Arm B)

5.Prior Pemetrexed dose for treatment but Cisplatin does can be no more than 75mg/2.

6 Male or Females greater than 18 years of age

7.Perfomance status is 0-1 Karnofsky greater than 70%

8.Life expectancy is greater than 3 months

9.Patients must have normal organ and marrow function

10. For patients who are in Arm A or Arm B, the disease must be measurable (pleural effusions and ascites are not measurable disease)

11. Patients must be able to swallow whole capsules. Nasogastric tubes or G tubes are not acceptable

12. Since this is a clinical trial it is unknown the effects to unborn fetus. Patients must agree to adequate contraception for the duration of trial

Exclusion Criteria

  1. Patients who have received chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier. Patients who have targeted therapy will have to wait 2 weeks due to short life of drugs.
  2. Patients who are receiving any other investigational drugs
  3. Patient with active brain metastases. Patients with treated brain metastases and have remained stable for greater than 4 weeks, without steroid and anti -seizure medicine, are able to participate. History of allergic reactions to compound or similar ingredients to TRC102 or Pemextred and Cisplatin
  4. As part of the informed consent patients will be counseled on the risk of over-the-counter medication or new prescription medications.
  5. Uncontrolled illness
  6. Pregnant and breastfeeding
  7. HIV patients on anti-viral therapy are ineligible
  8. Patients with known disorders that have hemolysis
  9. Patients on anticoagulation and thromboembolic disease
  10. Uncontrolled malignant pleural effusion or ascites
  11. Patients who have a cumulative does of Cisplatin greater than 300M2

How the research study is designed to work- Methoxyamine, or TRC102 is a medication taken by mouth? It is a small molecule inhibitor with potential adjuvant activity. It works by binding apurinic / apyrimidinic (AP) DNA damage sites and inhibits base excision repair (BER) which may result in an increase in DNA strand break and apoptosis. Apoptosis equals cell death. This agent may potentiate the anti- tumor activity of alkylating agents. The different arms of the study are trying the medications with certain cancers at different points. This study is being done concurrently with other cancers as well as mesothelioma.

With any clinical trial, all participation is voluntary. Before enrollment a detailed consent form will be reviewed with the participant and signed.

The participant can withdraw from a clinical trial at any point in time. Think about participating if you are able.

Feel free to contact us with any questions through this website.

 

Mesothelioma Clinical Trial Review – Pembrolizumab at University of Chicago

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u-chicagoOn www.ClinicalTrials.gov there are 3 listings involving mesothelioma and Pembrolizumab.

The first clinical trial listed is for malignant mesothelioma patients only.

We will be featuring this trial below. This is the only mesothelioma-exclusive clinical trial listed.

The second trial is not yet recruiting. It will include other cancers as well. The title is: A Trial of CDX-1401 in Combination With Poly-ICLC and Pembrolizumab, in Previously Treated Advanced Solid Tumor Patients.

The third trial is ongoing and recruiting, it involves other cancers besides mesothelioma, is at multiple sites, and for people whose cancers have progressed on standard therapy. It is titled: Study of Pembrolizumab (MK-3475) in Participants with Advanced Solid Tumors (MK-3475-158/KEYNOTE-158)

Clinical Trial- NCT02399371

Pembrolizumab in Treating Patients With Malignant Mesothelioma

Official Title: A Phase II Study of the Anti-PD-1 Antibody Pembrolizumab in Patients with Malignant Mesothelioma

Listing on www.clinicaltrials.gov

Sponsor- University of Chicago

Principal Investigator- Hedy L Kindler M.D.

Contact: Hedy L. Kindler 773-702-0360 hkindler@medicine.bsd.uchicago.edu

Number of Participants- 65

Purpose:

This clinical trial is for patients with malignant mesothelioma. It is for both peritoneal and pleural mesothelioma, and for cell types, (epithelioid, biphasic , sarcomatoid) the most common ones. It also includes recurrent peritoneal and pleural mesothelioma. It is a Phase II trial. The drug Pembrolizumab is a monoclonal antibody. The way monoclonal antibodies work is by blocking a protein called programmed cell death 1 (PD-1) which may stimulate an immune response and kill tumor cells.

Screening:

Pemnrolizumab focuses on a protein called PD-L1 which is expressed by mesothelioma types of tumors. You must have enough tissue for diagnosis so 3 biomarkers can be studied. You must have an archived specimen of your tumor or you will need to have a biopsy . Your disease must be measurable. A recent CT scan could have the information required. You must have had chemotherapy and either finished treatment or were unable to tolerate chemotherapy. Your tumor specimen will be submitted to Merck and will be tested for the bio-markers. This process takes approximately 3-4 weeks.

Eligibility Criteria

Age 18 or older, male or female, histologically or cytologically confirmed pleural or peritoneal malignant mesothelioma, epithelial, sarcomatoid, or biphasic subtypes. Only for part B-PD-L1 selection should a PD-L1expression threshold have been defined in Part A and potentially additional mesothelioma trial data; there will be no PD-L1/biomarker selection for Part A, no more than 2 prior lines of cytoxic therapy, which should have included pemetrexed and a platinum. Enrollment of treatment naïve patients who refuse standard chemotherapy or are intolerant may be permissible if reviewed and deemed clinically appropriate by the principal investigator.

Disease progression on or after pemetrexed and cisplatin or carboplatin (These are the first ones listed there are more- check on www.clinicaltrials.org ).

Exclusions:

Patients who are currently participating in or have participated in a study of investigational agent or have used an investigational device within 2 weeks (4 weeks for monoclonal antibodies) of the first dose of treatment. Also, patients that: have had side effects from prior treatment which have not resolved to =

How the Research Study is Designed to Work:

Pembrolizumab is infused through an I.V. over 30 minutes on day 1. Treatment repeats every 21 days for up to 24 months in the absence of disease progression or unacceptable toxicity. Patients may be eligible for up to 1 year of additional pembrolizumab therapy if they progress after stopping pembrolizumab.

As with any clinical trial you are free to withdraw at any point during the process.

Mesothelioma Clinical Trial Review

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c-trialsWe encourage participation in clinical trials for research leading to a cure for mesothelioma. It is known that nationally the statistics for participation in adult cancer trials is between 3-5% of adults who have a cancer diagnosis.

For mesothelioma patients and families who are interested in clinical trials, researching clinical trials and eligibility can be a time consuming barrier to participation.   The information about clinical trials is available on www.clinicaltrials.gov .

Our goal is to feature one mesothelioma clinical trial monthly and break it down to understandable terms, to decipher the eligibility requirements, and to possibly encourage participation in these trials.

CLINICAL TRIAL – NCT02004028

Window of Opportunity Study of VS-6063 (Defactinib) in Participants With Surgical Resectable Malignant Pleural Mesothelioma

Official Title- An Open Label Window of Opportunity Phase 11 Study of the FAK Inhibitor VS-6063 in Participants With Surgical Resectable Malignant Pleural Mesothelioma

Listing on www.clinicaltrials.gov

Sponsor-Verastem Inc.

Location- Brigham and Women’s Hospital Boston Massachusetts

Principal Investigator- Raphael Bueno M.D.

Contact- Julianne Barlow- 617-525-8541 jbarlow1@partners.org

Number of Participants- expected to be around 25

Purpose- This clinical trial is for people who have been diagnosed with malignant pleural mesothelioma and are a candidate for surgery. It is a drug given at specific times before surgery to participants who meet the eligibility criteria. The drug is a FAK inhibitor, named Defactinib. This drug will be given prior to surgery. Current therapy is surgery followed by chemotherapy and other treatments. The drug is a type of enzyme inhibitor that blocks the activation of specific signaling pathways in the body. The theory is that blocking these path ways may prevent tumor cells from growing and migrating to different areas of the body. After taking this drug, surgery will be scheduled about 7 days after completion.

Screening- Some of these tests you will undergo if you are considering surgery with or without this clinical trial.

  • A medical history
  • physical exam
  • vital signs
  • performance status
  • pulmonary function tests
  • quantitative ventilation-perfusion scan
  • PET scans
  • MRI for evaluation of your tumor
  • blood tests for biomarkers in addition to routine blood draws, biomarkers are genes or proteins that may predict how your body will respond to the study drug,
  • EKG
  • Pregnancy test if needed.

Eligibility Criteria

  • The patient must have a confirmed diagnosis of malignant pleural mesothelioma. The disease is confined to one side of the chest.
  • Be older than 18, male or female, not pregnant, be a candidate for surgery.
  • Tissue is required prior to enrollment. If patient was diagnosed outside and tumor tissue is not available, a pleural biopsy for frozen tissue collection is required.

Exclusions

  • Participants who have had chemotherapy or radiotherapy for mesothelioma any time prior to entering the study.
  • Patients receiving chemotherapy type drugs for benign conditions can participate in this trial. History of upper gastrointestinal bleeding, ulceration, or perforation within 12 months prior to the first dose of the study drug.
  • Known history of Gilbert’s Syndrome or any current hyperbilirubinemia of any cause.
  • Known history of stroke or cerebrovascular accident within 6 months prior to the first dose of the study drug.
  • Known infections with human immunodeficiency virus (HIV) or Acquired Immune Deficiency Syndrome (AIDS).
  • Confirmed Hepatitis A, B, or C.
  • Being actively treated for a secondary malignancy or any malignancy within the last 3 years, with the exception of nonmelanomatous skin cancer or localized, definitively treated cervical cancer.
  • Men under observation for local prostate cancer are also eligible if they have had stable disease for at least 1 year.
  • Uncontrolled or severe cardiovascular disease, including myocardial infarct or unstable angina within 6 months prior to study treatment.
  • Known history of malignant hypertension.
  • Uncontrolled intercurrent illness including symptomatic congestive heart failure, cardiac arrhythmias, or psychiatric illness/ social situations.

How the Research Study is Designed to Work

If you are eligible, a biopsy will be done if you don’t have previous tissue available to evaluate the specimens and biomarkers. After the biopsy- the participant starts taking the study drug by mouth twice a day for 35 days. The participant will have a study drug dosing diary. The tumor will be assessed by scans – CT, MRI, and a PET- CT at different points in the study. Different days will require clinic visits at specific times during the trial.

With any clinical trial, all participation is voluntary. Before enrollment a detailed consent form will be reviewed with the participant and signed.

The participant can withdraw from a clinical trial at any point in time. Think about participating if able, the only way progress to a cure for mesothelioma can be made is through clinical trials.

  • This field is for validation purposes and should be left unchanged.

Your message to us will be held in strict confidence. All requests for information by mesothelioma patients and their family members will be answered within 24 hours. Mesothelioma Treatment and Care Guides are sent to mesothelioma patients and families by overnight delivery.

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